Randomized Amifostine For SCCHN

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Amifostine is a drug that is used to treat moderate to severe xerostomia (dry mouth) for those who receive radiation therapy for head and neck cancer. It was approved by the FDA for use intravenously. This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously (by injection). Amifostine has been seen to be effective when used to combat the effects of dry mouth, but also has some side effects which are listed later in this consent form.

The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel (Taxo 1). This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation.

4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).

Subcutaneous daily amifostine at a dose of 500 mg

Drug: Amifostine

Given subcutaneously

Other Name: Ethyo

Drug: Carboplatin

Given IV

Other Name: Paraplatin

Drug: Paclitaxel

Given IV

Other Names:

Taxol

Onxal

Radiation: radiation

Given once daily for 4 weeks and then twice daily for 2 weeks.

Experimental: Arm B No-Amifostine

Patients with newly diagnosed, locally advanced stage ill or IV SCCHN

- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Histologically or cytologically proven squamous cell carcinoma of the head and neck. Biopsy is preferred unless medically contraindicated.

Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary SCC in the neck will also be eligible.

Patients must be available for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centers

Previous chemotherapy is permitted, provided that it is in induction form before starting radiation therapy and that it is being used to treat head and neck cancers.

Exclusion Criteria:

Pregnant or lactating women, or women of childbearing potential not using adequate contraception.

Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 3 years.

Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria.

Other serious illnesses or medical conditions including but not limited to: